OKILYS suite
Tools born in the field of clinical trials
OKILYS Suite is the eClinical range edited by OKILYS Life Science: tools born from cross-cutting field expertise — different roles, different companies, different studies — serving the teams who move studies forward day after day — biotechs, sponsors, CROs and hospitals — with the means and headcount of small organisations.
Why these tools exist
Twelve years holding every position of the chain — site coordination, monitoring, start-up and contracts, study management, oversight — showed the same thing everywhere: studies rarely stall on the science — almost always on the organisation and on scattered communication, written and spoken alike: the same information to update manually in several places, and someone to remember to inform every time.
The Excel tracker that drifts
Site list, follow-up actions, CRA oversight, training: one file per topic, shared by e-mail or SharePoint, with its off-list entries, lost rows and wrong dates. Every progress meeting started with a reconciliation. And a file that stays editable by everyone means a weak audit trail — and the permanent risk of changing something without meaning to.
The same information typed many times
A visit date copied into the site record, the tracker, the weekly-call minutes, the checklists and the visit reports. So many chances to get it wrong, to miss an update — and to generate findings.
Tools hardly accessible to small organisations
Market platforms are built for large companies: licences, deployments and training beyond the reach of small organisations running a few studies with a limited team.
A conviction
A useful tool follows the team's real work without scattering its energy: what is entered once propagates everywhere, what is done is traced, what is missing is visible before it costs time, data or patients.
The suite
Two products sharing the same base, the same accesses and the same principles; others will follow the needs of the field.
OKILYS CTMS
Site feasibility, selection and activation, visits and signed reports, follow-up actions, submissions and contracts, study documents and training, CRA calls, planning, safety: everything needed to run a trial from A to Z, in modules on demand.
Discover OKILYS CTMS →OKILYS eTMF
The electronic Trial Master File connected to the CTMS: documents produced during the study are filed automatically in the right section, your teams verify them, completeness is read continuously.
Discover OKILYS eTMF →Client access to the CTMS: ctms.okilys.com ↗
What stays the same from one product to the next
Modular, at the scale of your budget
You enable only the blocks useful to each study; a module can be subscribed on its own, without volume commitment.
Your data stays yours
Dedicated hosting in France, nightly backups, data package on demand and full hand-back at the end of the partnership.
Compliance by design
Named accounts and two-factor authentication, ALCOA+ audit trail, traced, tamper-evident electronic signatures, GDPR, ICH E6(R3).
Designed by OKILYS, developed by INFRARCH
The specifications come from the field — from roles held and teams' real needs; development is delivered by INFRARCHNetwork, Security & Automation An engineering company from the Jura. Every user feedback feeds the next version.